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Sympathetic Nerve Activity and an Implantable Cardioverter Defibrillator in Heart Failure Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University Hospital, Toulouse
ClinicalTrials.gov Identifier:
NCT00439790
First received: February 23, 2007
Last updated: June 12, 2012
Last verified: June 2012
History of Changes
  Purpose

The aim of this study is to analyze whether the sympathetic tone, measured indirectly and directly by muscle sympathetic nerve activity recording, is elevated in patients with heart failure receiving an appropriate shock from their implantable cardiac defibrillator (ICD) compared to heart failure patients not receiving a shock from their ICD. All parameters measured in this study will be used to build a risk algorithm able to identify heart failure patients at high risk for sudden cardiac death who could receive an ICD.


Condition Intervention
Heart Failure
Death, Sudden, Cardiac
 Procedure: Microneurography

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Validation of a Prognostic Score to Identify Heart Failure Patients Who Might Need an Implantable Cardioverter Defibrillator Using Muscle Sympathetic Nerve Activity and Autonomic Testing

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Hospital, Toulouse:

Enrollment: 109
Study Start Date: January 2007
Study Completion Date: December 2011
Intervention Details:
    Procedure: Microneurography
    Microneurography
Detailed Description:

We plan to perform an extensive study of the sympathetic nervous system activity in heart failure patients with an ICD. The SNS activity will be measured directly by a recording of the muscle sympathetic nerve activity and indirectly by post processing of 24-hour Holter recording, catecholamine levels assessment, and spontaneous baroreflex sensitivity. A global assessment of the patients status will also be realised. Patients will be followed for one year. During follow up, this cohort will be divided into two groups according to the occurrence or not of an appropriate shock. We assume that an appropriate shock is a surrogate marker for sudden cardiac death. We plan to compare the autonomic nervous system activity in both groups of patients in order to identify a score able to detect heart failure patients at high risk for sudden cardiac death.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Heart failure patient

Criteria

Inclusion Criteria:

  • Heart failure patient with an ICD

Exclusion Criteria:

  • Pregnant patient
  • Acute coronary syndrome within the last 3 months
  • Peripheral neuropathy.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00439790

Locations
France
Cardiologie, University Hospital
Toulouse, France, 31400
Sponsors and Collaborators
University Hospital, Toulouse
Investigators
Principal Investigator: Atul Pathak, MD Hospital University Toulouse
  More Information

No publications provided

Responsible Party: University Hospital, Toulouse
ClinicalTrials.gov Identifier: NCT00439790     History of Changes
Other Study ID Numbers: 0602508
Study First Received: February 23, 2007
Last Updated: June 12, 2012
Health Authority: France: French Data Protection Authority

Keywords provided by University Hospital, Toulouse:
implantable cardioverter defibrillator
Heart failure
Sudden Cardiac Arrest
appropriate shock
Defibrillators, Implantable

Additional relevant MeSH terms:
Death, Sudden
Heart Failure
Death, Sudden, Cardiac
Death
 Pathologic Processes
Heart Diseases
Cardiovascular Diseases
Heart Arrest

ClinicalTrials.gov processed this record on May 16, 2013